SB 175-PRACTICE OF NATUROPATHY  1:39:25 PM CHAIR EGAN announced consideration of SB 175 [version 27- LS1230\M]. He said that public testimony was still open. SENATOR GIESSEL moved to adopt Amendment 1. 27-LS1230\M.4 AMENDMENT 1 OFFERED IN THE SENATE SENATOR GIESSEL TO: SB 175 Page 1, line 13, through page 2, line 2: Delete all material and insert: "* Sec. 2. AS 08.45.050 is amended by adding new subsections to read: (b) Notwithstanding (a)(1)(A) of this section, a person who practices naturopathy may give, prescribe, or recommend in the practice a device or, in a form that is not a controlled substance, an herbal or homeopathic remedy, a dietetic remedy, or hydrotherapy. (c) In this section, (1) "dietetic remedy" means nutritional therapy, nutritional counseling, a nutritional substance, vitamins, minerals, or supplements to promote health and to diagnose, treat, or prevent disease, illness, or conditions; (2) "herbal remedy" means a substance derived from or a concentrate or extract of a plant, tree, root, moss, or fungus; (3) "homeopathic remedy" means a remedy defined in the current version of Homeopathic Pharmacopoeia of the United States; (4) "hydrotherapy" means the use of water in all forms and temperatures to promote health and to diagnose, treat, and prevent disease, illness, and conditions." SENATOR GIESSEL explained that this amendment would replace Section 2 of the bill. 1:40:30 PM SENATOR PASKVAN objected for purposes of discussion. 1:41:25 PM MARY MINER, Naturopathic Doctor (N.D.), Fairbanks, Alaska, said Valentine's Day is the 28th anniversary of her being licensed in Washington State. She supported SB 175 as amended. She has been well trained and does not want to limit the services she is able to deliver to her patients and has a sense of urgency because these services wouldn't be available to them otherwise. They would have to go to their other provider who wouldn't have a clue what they are. 1:44:18 PM MADELEINE MORRISON, Alaska Association of Naturopathic Doctors, Anchorage, said she had practiced in Alaska since 1996 and agreed with Ms. Miner's testimony. She added that she works with M.D.s on a regular basis together with patients for the best possible outcome. 1:45:27 PM WARD HURLBURT, Chief Medical Officer, Department of Health and Social Services (DHSS), Anchorage, said the administration has concerns with SB 175 because it could either potentially or in reality expand the scope of naturopathic practice. Dr. Jackson, who testified at an earlier meeting, said that he ran into a problem with a prescription being required for capsicum. Their Chief Pharmacist did some research and talked with the company that manufactures it and found that it was their decision to put on the box that a prescription be required, not something the FDA did. He said the state has in the past considered that naturopathic doctors do not have prescribing authority and believes that the bill would expand it, which would incur a cost. Dr. Jackson said his understanding is that authorizing prescriptions for substances derived from plant, trees, roots, moss and fungus would include substances like penicillin. Fifteen to twenty percent of drugs used by allopathic and osteopathic physicians are originally derived from natural substances. Some confusion may be because of different training and vocabulary used for the disciplines. Dr. Jackson testified that in his training drugs and medicines are different; the drugs are synthetic chemical substances whereas the medicines more broadly include natural substances. Mr. Hurlburt said in his training those terms are interchangeable. SENATOR MENARD clarified that vitamins are from natural sources and are sometimes put into 11 percent of prescription-type drugs to enhance them. MR. HURLBURT answered they are not talking about vitamins. Examples of other kinds of pharmaceuticals that are derived from plants would be digitalis, used for heart failure, and quinine, originally an anti-malaria drug, some anti-cancer drugs and penicillin. SENATOR GIESSEL said the current definition in regulation for naturopath says herbal remedies include "medicines derived". The amended form of the bill says herbal remedy means "a substance", the effort there being to separate digitalis from an herbal preparation. Did he not think that was clear enough that it's not a prescription, pharmaceutical agent? MR. HURLBURT replied his initial take is that it would clarify it, but their Chief Pharmacist felt the language in the amendment was broad enough to lead to some confusion in saying they are derived from natural substances and opened the possibility of prescribing things like digitalis and anti-cancer drugs. SENATOR GIESSEL asked if a clearer statement would have a semicolon and another phrase that says, "these substances do not include pharmaceutical agents." MR. HURLBURT answered yes. 1:53:03 PM MARY DESMETT, representing herself, Juneau, said she is a consumer and patient of both naturopathic and allopathic care. Her life had been profoundly affected in a positive way by being able to choose when to see a naturopathic doctor or a western doctor. She was well on her way to type 2 diabetes and now her labs are all good and she is off every medication including an anti-depressant. 1:54:32 PM C.W. JASPER, N.D., said he supported SB 175 and the amendments. He enjoyed meeting with Dr. Hurlburt, but the concerns about anti-cancer drugs that may come from an herb or digitalis forgets an important issue - that every health care provider is limited by his training and education. And even though this definition in the regulations might have allowed the use of those anti-cancer drugs in the last 18 years, the fact of the matter is that nobody has used them for the last 18 years, because that is not what their training is. That is the safety factor. Digitalis is always mentioned because it's a famous herbal medicine, but nobody uses it anymore. Penicillin was brought up, and the definition would allow it, but after speaking to many colleagues on the phone he found that no one knows of any naturopath who has used it in the last 18 years, just that the definition would allow it. But again, he said they practice what they are trained to do. He just didn't think it was an issued because it's not part of naturopathic practice based on their training. 1:56:36 PM SENATOR PASKVAN asked what notice he received of any change from the department or division. DR. JASPER replied none. He had a nice meeting with Mr. Habegar this morning who wasn't aware of putting out any notice to that effect and didn't know where it came from; he was checking into it. 1:58:07 PM SENATOR PASKVAN asked how long naturopaths have used pharmacists. MR. JASPER answered for the past 18 years pharmacists have honored their prescriptions, but for just very few things, because there aren't a lot of prescription drugs. SENATOR PASKVAN asked for 18 years consistent with the statutes and administrative codes of Alaska. MR. JASPER responded that was correct. SENATOR GIESSEL asked what he would think if she amended item 2 in Section 2 to say "herbal remedy means a substance derived from; substance does not mean pharmaceutical agent." MR. JASPER said he thought it would be confusing because it would add an undefined word to the definition. 2:01:02 PM MARY ALICE MCKEEN, representing herself, Juneau, said she is a consumer of naturopathic care and an administrative judge for the federal government. She supported SB 175 and appreciated all the efforts to solve this problem, because people want access to this type of care. In 1986 the legislature made a policy decision that people in Alaska should have access to it and severely restricting the scope of practice [for naturopaths] really undermines that decision. Referencing the department's letter that said patients could use substances in their natural form, she remarked the legislature did not intend for naturopaths to recommend that patients grind up their own red pepper but that they could obtain a capsicum tincture by prescription. She said the regulation answers that squarely because it says in 12 AAC 42.990(a) that a prescription drug does not include a device or herbal or homeopathic remedy or dietetic substance in a form that is not a controlled substance. It doesn't say it has to be in its natural form; it really answers the form question by saying the prescription drug cannot be in a form that is not a controlled substance. MS. MCKEEN said this new interpretation didn't have any notice or comment period but the regulations have all gone through a notice and comment procedure and the public got a chance to weigh in. If there was a proposed regulation that said "prescription drug" means everything you need a prescription to get, people would come out and testify against it and she mused that in a way, this is the comment period for this new interpretation. 2:05:07 PM MARTIN NEIMI, representing himself, Juneau, said he is a 69 year-old patient of a naturopathic doctor and old enough to choose which kind doctor to see first. The way he views his choices is that the naturopathic doctor guides him to a better and healthier life style and when it gets to the point of needing drugs or surgery, he will go to a medical doctor. He summarized that he was a P.E. and health teacher before he retired and knows a little bit about health care and has had a wonderful experience with naturopathic doctors. 2:06:12 PM DON HABEGAR, Director, Division of Corporations, Business and Professional Licensing, Department of Commerce, Community and Economic Development (DCCED), came forward to answer questions. SENATOR PASKVAN asked if he agreed that naturopaths didn't have any notice of this change. MR. HABEGAR replied that his staff hadn't released any kind of formal information to pharmacists or naturopaths, but he was still looking into it. SENATOR PASKVAN said that answer seems to infer that no process was followed, so there was no foundation for his position in the last meeting. MR. HABEGAR said in the last meeting he referred to recent licensure action and he also referred to what appears to be a consistent no prescriptive authority position based on the division's history. SENATOR PASKVAN asked if he agreed that whatever the source, there had been a material restriction in the naturopath's ability to access pharmacies as part of their practice from what has occurred over the last 18 years. MR. HABEGAR replied he agreed that that is the issue before everyone and that is what they are saying, but he personally didn't have any evidence of it. SENATOR PASKVAN said everything he is hearing says that there are statutes going back to 1986 and administrative regulations that go back to 1994 and it appears that they have solid practices going back 18 years. No notice was given to the naturopaths, and that implies there was no opportunity for them to be heard. Therefore, something has occurred that appears to be arbitrary and capricious. Whatever the source, he was pretty troubled. 2:10:14 PM ANDY HARRINGTON, Assistant Attorney General, Civil Division, Commercial and Fair Business Section, Department of Law, Juneau, responded that a complaint was filed about a naturopath for using or administering prescriptive drugs in 2008. During the investigation, the division asked the naturopath where and how the prescription drugs were being obtained and the naturopath indicated an unwillingness to provide that information. Then the division served several local pharmacies with administrative subpoenas regarding any prescriptions they may have filled for the naturopath. The division investigator gave a heads up to the Pharmacy Board as to why the subpoenas were being served. The Pharmacy Board eventually sent a cautionary letter to the one pharmacy that had been filling the prescriptions. He surmised, Alaska being a small state, that word of the subpoena and perhaps the letter got discussed on the pharmacist grapevine and passed along. So, it is not surprising that other naturopaths in other parts of the state found pharmacists who may have normally been filling prescriptions written by naturopaths were less willing to do so. MR. HARRINGTON said that any pharmacist either in state or out who called him would have been told that Alaska statute very clearly prohibits naturopaths from giving, prescribing or recommending in the practice a prescription drug. The division felt compelled to interpret its regulations consistent with that statutory prohibition. Director Habegar is correct that since shortly after the regulations were enacted the division has consistently taken the position that the regulations did not forge any kind of an exception to the statutory prohibition. It is also fair to say that the naturopaths who were saying they assumed the regulations trumped the statute are also being very truthful in their testimony, but regulations don't trump statute. 2:14:32 PM SENATOR PASKVAN asked why it isn't appropriate to allow a practice that has been in place for 18 years to continue while the legal issue is addressed since it appears the risk is nonexistent. MR. HARRINGTON replied that it is appropriate because the problem arises from a mismatch between language of the statute with its fairly clear prohibition and the language of the regulations, which leaves much room for debate. If the statute is not changed to correspond to regulatory language, the division would have to go through the notice and public comment procedure to propose a regulatory change that would be more in accordance with the statute, AS O8.45.050(1)(A). But the division has wisely decided to await the outcome of the legislative process and is neutral as to the merits of the bill, but recognizes the current situation is pretty untenable. Naturopaths and their patients and the people in the division who are trying to administer this law are all disserved by the confusion created for everyone. 2:17:52 PM SENATOR GIESSEL said AS 08.45.200 says naturopathy means the use of hydrotherapy and dietetics and later says that "dietetics includes herbal and homeopathic remedies" and those are not defined there; they are defined in regulation and that is the definition that is being offered in this bill. SENATOR DAVIS asked if a pharmacist was on line. She heard someone from a pharmacy say that they had been giving out the medicine but had received information saying it was illegal to do so. CHAIR EGAN said Dr. Hurlburt said that. SENATOR DAVIS said she had been trying to increase the scope of practice for naturopaths for years and hasn't gotten anywhere. This bill doesn't give them any more authority, but it would put current practice in statute and she was ready to move it. SENATOR PASKVAN removed his objection to the Amendment 1. CHAIR EGAN said he would hold SB 175 in committee.